Kornimate/medical-research-clean huggingface dataset:
the swiss glucose variability study

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to explore long term glucose variability of a combination therapy of metformin and vildagliptin compared to a metformin - gliclazide combination. multicenter, randomized, open, parallel group, phase iv study, of 18 months duration. * trial with medicinal product


Eligibility criteria:
inclusion criteria: 1. male or female patients aged =30 -= 75 years. 2. history of type 2 diabetes for at least 6 months. 3. patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with hba1c of 6.5-9.0%. 4. patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with a body mass index (bmi) of 25-40 kg/m2. 5. patients that are currently treated with metformin, gliclazide or both but not with other glucose lowering agents. 6. outpatient. 7. if female of childbearing potential: will to practice reliable birth control measures \[e.g., surgical sterilization, hormonal contraception, double-barrier methods (any double combination of iud, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)\] during study treatment and for at least 28 days after completion of study medication; not lactating or pregnant; and has a documented negative pregnancy test result at baseline. exclusion criteria: 1. type 1 diabetes as defined by the american diabetes association (ada). 2. type 2 diabetes currently (last 3 months) treated with insulin or glitazones. 3. acute or chronic diseases causing tissue hypoxia such as: * cardiac or respiratory insufficiency * myocardial infarct within the last 6 months 4. active liver disease with alanine aminotransferase (alat) and / or aspartate aminotransferase (asat) \> 3 x upper limit of normal. 5. relevant kidney disease such as : * serum creatinine =133 µmol/l in males and \> 124 µmol/l in females * proteinuria \> 300 mg/l * status post kidney transplantation * severe infection * intravascular administration of contrast medium containing iod within the last 7 days 6. severe neuropathy (vibration perception at the base of the big toes \<2/8). 7. active proliferative diabetic retinopathy. 8. any clinically relevant major organ system disease including mental illnesses 9. history of malignancy 10. pancreatitis 11. porphyria 12. severe disturbances of the adrenal gland 13. severe disturbances of the thyroid gland 14. allergy to vildagliptin or one of the excipients 15. allergy to metformin or one of the excipients 16. allergy to gliclazide, sulfonylurea or sulfonamides or one of the excipients. 17. drug or alcohol abuse. 18. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine). 19. any other condition that could interfere with the participation in the study according to the study protocol or with the ability to cooperate and comply with the study procedures. 20. treatment with any investigational drug, within 30 days or 5 half-lives before screening, whichever is longer.
high fructose corn syrup

Conditions: Nonalcoholic Fatty Liver Disease; Obesity

Summary: the purpose of this research study is to learn more about how high fructose corn syrup, a sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without nonalcoholic fatty liver disease. eligible participants will be studied before and after eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn syrup) for four weeks.


Eligibility criteria:
inclusion criteria: * ihtg \>6.5% or \<5% * bmi 30.0-45.0 kg/m² * sedentary * consume \<10% calories from high fructose corn syrup * weight stable for previous 3 months exclusion criteria: * ihtg 5.1-7.9% * children * adults over 65 years * pregnant * lactating * exercise \>1.5 hours/week * hepatitis b or c * diabetes * history of liver disease * history of alcohol abuse * severe hypertriglyceridemia (\>300 mg/dl) * smokers * anemia (hemoglobin \<10mg/dl) * not weight stable

Keywords: obesity nonalcoholic fatty liver disease high fructose corn syrup
a phase 2 study of asp1585 in chronic kidney disease patients with hyperphosphatemia on hemodialysis

Conditions: Hyperphosphatemia; Chronic Kidney Disease

Summary: to evaluate the superiority to placebo, dose-responsibility and safety.

this is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in ckd patients with hyperphosphatemia on hemodialysis. patients will be randomly allocated to one of the five treatment groups (asp1585: 3 dose, placebo, sevelamer hydrochloride) and advance to the 4-week treatment period.

Eligibility criteria:
inclusion criteria: * stable ckd patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent * patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent. * patients on stable dose(s) of vitamin d or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents exclusion criteria: * history of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion * continuous severe constipation/diarrhea. * history of parathyroid intervention \[parathyroidectomy（ptx），percutaneous ethanol injection therapy（peit）etc.\] within 1 year of the acquisition of informed consent * diet restriction such as fasting and/or excessive dieting * uncontrolled hypertension

Keywords: asp1585 renal dialysis chronic kidney disease hyperphosphatemia
breast mri for neaodjuvant chemotherapy response prediction and evaluation in breast cancer

Conditions: Breast Cancer

Summary: the aim of this retrospective study is to evaluate the value of pre-treatment and post-treatment multimodality mri study, including quantitative evaluation of background parenchymal enhancement, for response prediction and evaluation. this study will include 100 patients treated in a single institution between 2011 and 2016


Eligibility criteria:
inclusion criteria: * adult patients * patients with breast cancer treated with neoadjuvant chemotherapy * patients with pre- and post-chemotherapy mri * patients who have given their agreement to use their data for research purposes. exclusion criteria: - refusal to participate in the study

Keywords: breast cancer neoadjuvant chemotherapy
phase 2/3 study of tlc590 for postsurgical pain management

Conditions: Postsurgical Pain Management

Summary: a phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery.

this is a phase 2/3 randomized, double-blind, 2-part, comparator- and placebo-controlled study to assess the safety, pharmacokinetics and efficacy of postsurgical local infiltration in adult subjects following inguinal hernia repair surgery. this study includes 2 parts. an unblinded interim analysis will be performed after completion of part 1 (phase 2, approximately 115 subjects to be randomized for 2 different doses of tlc590, bupivacaine, ropivacaine, or placebo), for selecting a tlc590 dose for part 2 (phase 3, approximately 300 subjects to be randomized for tlc590, bupivacaine, or placebo).in this study, 2 doses of tlc590 24.5 mg/ml in inguinal hernia repair will be assessed in an initial phase 2 part before proceeding to a phase 3 pivotal evaluation.

Eligibility criteria:
inclusion criteria: * male or female at least 18 years old * bmi 18-39 kg/m2 * scheduled to undergo a primary, unilateral lichtenstein inguinal hernia repair with mesh * asa physical status classification of 1, 2 or 3 exclusion criteria: * clinically significant abnormal clinical laboratory test value * clinically significant 12-lead ecg * history of orthostatic hypotension or syncope * history of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition * history of seizure or currently taking anticonvulsants * history of hypersensitivity to bupivacaine/ropivacaine, any other amide-type local anesthetic, propofol, oxycodone or morphine (or other opioids) * history of severe or refractory post-operative nausea or vomiting (ponv) * abnormalities of laboratory parameters: hba1c, platelet, hemoglobin, wbc, serun bilirubin/alanine aminotransferase/aspartate aminotrasferase, serum creatinine, ptt/inr * concurrent acute, or chronic painful restrictive/physical condition * received opioid therapy for longer than 4 days per week * prohibited medication: aspirin and other anti-platelet medication, anticoagulants, class iii antiarrhythmic drugs, strong cyp1a2 inhibitors,systemic corticosteroids, nsaid, opioid, bupivacaine or ropivacaine, any investigational product * history of drug abuse or alcohol abuse * positive results on the urine drug screen or alcohol breath test * history of hiv; active hbv or hcv * an inguinal hernia repair in the last 3 months or has undergone 3 or more surgeries within 12 months * malignancy in the last 2 years * documented sleep apnea or on home continuous positive airway pressure treatment (cpap) * personal or family history of malignant hyperthermia.
isolated rectal bleeding in newborns : allergic proctocolitis or neonatal colitis transient - colon study

Conditions: Isolated Rectal Bleedings

Summary: prospective observational pilot study evaluating the frequency of cow's milk protein allergic prococolitis in newborns hospitalized in neontal medicine at the university hospital of nice who presented rectal bleeding.

inclusion of all newborns in the neonatal medicine department at nice university hospital with isolated rectal bleeding. a note of information and non-opposition will be presented and given to the biological mother. she has the right to object to this study, on her own initiative, at any time. collection of data relating to the newborn during hospitalization, the results of the clinical examination and the systematic check-up carried out in accordance with standard practice, and data at discharge. follow-up of the newborn to determine the cause of rectal bleeding and therefore the frequency of procolitis allergic to cow's milk proteins. prospective observational study of current practices without any intervention.

Eligibility criteria:
inclusion criteria: 1. all newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia; 2. affiliated to social security ; 3. presenting isolated rectorrhagia defined as rectorrhagia without hematemesis/ repeated vomiting/ tense or distended abdomen/ apathy/ apnea/ bradycardia or signs of severity (tachycardia, desaturation, poor coloration); 4. after obtaining the biological mother's non-objection; exclusion criteria: 1. all newborns with ulcerative enterocolitis, congenital digestive malformations or rectorrhagia following digestive surgery; 2. opposition to participation in research involving the human person.

Keywords: allergic proctocolitis neonatal colitis transient cow's milk protein allergic
triptan use and serious vascular events in elderly over 65 years

Conditions: Migraine

Summary: this study will be conducted as a retrospective study of exposed and unexposed cohort of the french population included all beneficiaries aged 65 and older. exposed patients will be matched to non exposed controls according age, gender and area of residence (ratio 1/4). two exposed arms and two non exposed control arms will be planned. triptan arm will be user of triptan defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users"). ergot arm will be user of ergot derivative defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users"). this study involved data from the french national health insurance information system (système national d"information inter-régimes de l"assurance maladie ; sniiram) linked with the french hospital discharge database (programme de médicalisation des systèmes d"informations, pmsi). * the sniiram is a vast national medico-administrative database representing the most part of the french population, allowing to identify and to describe precisely all medication dispensations (name of drug, date of dispensing and quantity) including triptans and other reimbursed medications. * the pmsi provides medical information about all patients admitted to hospital in france, including discharge diagnoses encoded according icd-10, medical procedures and french diagnosis-related groups the research proposed is expected to provide an update and nationally-consolidated estimation of the cardiovascular risk is associated to triptans use in elderly population.


Eligibility criteria:
inclusion criteria: * patients aged 65 and more * patients registered in the sniir-am * to avoid depletion of susceptibles bias, only incident users will be included. incident users are defined by the lack of reimbursement for triptan (or ergot derivatives) prior six months of the study period. exclusion criteria: no exclusion criteria

Keywords: triptan drug utilization elderly drug abuse cardiovascular disease
comparison of oral aprepitant and transdermal scopolamine for preventing postoperative nausea and vomiting

Conditions: Nausea; Vomiting

Summary: recent evidence suggests multiple drug therapy is superior to single agents. the study compares the incidence of nausea, vomiting, need for rescue medication, prolonged pacu time, and unplanned hospital admission in patients with high risk for ponv treated with oral aprepitant with or without transdermal scopolamine preoperatively.

postoperative nausea and vomiting (ponv) is a serious problem complicating surgery. ponv has an overall incidence of 30% and a 70% incidence in high-risk patients. ponv yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (pacu). additional use of resources costs the health care industry hundreds of millions of dollars annually. patient satisfaction is greatly improved when ponv is prevented.4 ponv etiology is multifactorial and the treatment is multimodal.

Eligibility criteria:
inclusion criteria: * patient must be between 18 and 65 years of age. * patient's asa (american society of anesthesiologist) class must be between 1 and 3. * if patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study. * patient must have 1 factor to qualify * female sex * history of ponv * motion sickness * non-smoker * intended use of post operative opioids exclusion criteria: * patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition. * the surgical procedure is less than 1 hour. * the patient is pregnant or breast feeding. * the patient has taken antiemetic medication in previous 24 hours. * patients with narrow-angle glaucoma. * allergy to belladonna alkaloids. * hypersensitivity to barbiturates. * patient taking any of the following medications: * orap * seldane * hismanal * propulsid * phenytoin * phenothiazines * tricyclic antidepressants * meperidine * tolbutamide * aluminum and magnesium trisilicate-containing antacids * anti-cholinergics * coumadin * male patients with prostate hypertrophy. * patients with severe hepatic disease. * patients on chemotherapy and taking aprepitant. * patients with fever. * patients with sepsis.

Keywords: post-operative nausea and vomiting (ponv)
trk-100stp clinical study - chronic renal failure (primary glomerular disease/nephrosclerosis)

Conditions: Chronic Renal Failure; Glomerular Disease; Nephrosclerosis

Summary: in chronic renal failure (crf) patients with primary glomerular disease or nephrosclerosis as the primary disease: * to confirm the superiority of trk-100stp over placebo * to determine the recommended therapeutic dose in the 2 doses of trk-100stp * to assess the safety of trk-100stp


Eligibility criteria:
inclusion criteria: * the crf patient with primary glomerular disease or nephrosclerosis as the primary disease * the patient with progressive crf exclusion criteria: * the patient with secondary glomerular disease * the patient with crf caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis

Keywords: esrd chronic renal failure prostaglandin prostacyclin asian multinational study
markers of liver apoptosis after anesthesia with sevoflurane or propofol

Conditions: Liver Dysfunction

Summary: anesthesia may affect the function of vital organs. liver is one of them. the investigator's hypothesis is that intravenous or inhalation anesthesia does not impair liver function as assessed by more elegant tests like markers indicating liver apoptosis. in the present randomized prospective trial female patients scheduled for mastectomy or thyroidectomy will receive inhalation or total intravenous anesthesia and markers for liver dysfunction will be determined.

female patients undergoing mastectomy or thyroidectomy under sevoflurane or propofol anesthesia will be recruited for the study. the type of anesthesia will be determined in a random way using a computer generated table. all patients will be preoxygenated for 3 minutes before induction of anesthesia. patients assigned to the sevoflurane group will receive an inhalation induction with sevoflurane via a primed anesthetic circle system and anesthesia will be maintained with sevoflurane. in the propofol group patients anaesthesia will be induced and maintained with propofol. blood samples for liver apoptotic markers will be collected before induction of anesthesia, after skin closure as well as 24 and 48 hours postoperatively. blood samples will be centrifuged, stored at -80 degrees celsius and analyzed for m30 and m60 values with radioimmunoassay technique. serum glutamic pyruvic transaminase (sgpt) and serum glutamic oxaloacetic transaminase (sgot) levels will also be determined.

Eligibility criteria:
inclusion criteria: * female patients aged between 30 and 65 years old scheduled for thyroidectomy or breast surgery for cancer exclusion criteria: * drug intake which may affect liver function * severe cardiovascular or respiratory disease * hepatic or renal dysfunction * pregnancy * alcohol and drug abuse * body mass index (bmi) \> 35

Keywords: liver apoptosis
effects of immune function on prognositic outcome in critical ill patients with acinetobacter baumannii infection

Conditions: Acinetobacter Baumannii Infection

Summary: the purpose of the present study is to evaluate the effects of immune function on prognositic outcome in critical ill patients with acinetobacter baumannii infection.

this is a single-center, observational study. patients with acinetobacter baumannii infection in the intensive care unit of zhongda hospital were enrolled. we recorded the data of age, icu admission diagnosis, underlying diseases, apache ii score and infection site. body temperature, heart rate, white blood cell counts, procalcitonin, c-reactive protein, sofa score and the level of cd4+, cd8+, th1, th2 and hla-dr in the blood measured by flow cytometry on the d1, d3 and d7 were also recorded.we can get the results of the change of immune function of critical ill patients after acinetobacter baumannii infection. after compare the patients who die of survive at 28 day after infection, we can get the results of the relationship between the immune function and the outcome. we also can calculate the effect immune function on prognositic mortality in patients with acinetobacter baumannii infection.

Eligibility criteria:
inclusion criteria: * patients admitted to icu * infection with acinetobacter baumannii * agree to participate the study exclusion criteria: * age less than 16 years old or older than 80 years old * pregnancy * immunosuppression patients which include 1. therapy 0.5mg/kg/day of prednisoneover(equivalent dose of other glucocorticoids) for at least 1 month within recent 3 month 2. cancer chemotherapy within recent 3 month 3. receive immunosuppression treatment because of solid organ transplant or autoimmune diseases 4. allogeneic bone marrow transplantation or allogeneic haematopoietic stem cell transplantation. 5. hiv infection

Keywords: a baumannii infection immunosuppression prognosis immune function
hospital-based surveillance of rotavirus gastroenteritis in young taiwanese children

Conditions: Rotavirus Gastroenteritis, Young Taiwanese Children

Summary: rotavirus remains among the leading causes of pediatric gastroenteritis requiring hospitalization in the world. surveillance studies revealed that more than 90% of the global circulating rotavirus strains were predominated by several major genotypes. clinical trials and post-marketing studies have demonstrated that the currently available rotavirus vaccine can provide sufficient protection against strains of the prevalent genotypes. however, the emerging strains with new genotypes were increasingly reported in the past decade, an ongoing surveillance of the strain changes is needed in the regions where the pediatric population is either fully or partly immunized. in this project, the investigators will setup a hospital-based gastroenteritis surveillance network by incorporating 8 major hospitals in northern, central, southern and eastern taiwan. from 2013 to 2015, children aged 5 years or younger hospitalized to one of the 8 sentinel hospitals due to acute gastroenteritis will be screened for rotavirus infection, and viral proteins 7 \[vp7\] (g type) and viral proteins 4 \[vp4\] (p type) genotypes of rotavirus will be determined for each infected case. the demographics and clinical manifestations of study subjects will also be collected and analyzed. through this project, the investigators will be able to detect emerging genotypes of rotavirus and delineate the strain distribution during the two years of study in taiwan. the investigators can also have more comprehensive understanding of the epidemiology of rotavirus regarding to the incidence, disease characteristics, temporal and geographic variations of severe rotavirus gastroenteritis in taiwanese children. results from this project will provide valuable information for future implementation of mass immunization against rotavirus in taiwan.


Eligibility criteria:
inclusion criteria: * aged less than 60 months, * hospitalized in 1 of the 8 hospitals, * having diarrhea not caused by any known underlying diseases. exclusion criteria: * no